Method of performing a balloon kyphoplasty procedure using a scoop cannula

ABSTRACT

A method of treating a bone of a patient includes identifying a portion of the patient to be protected. A cannula is provided that includes a shaft extending between opposite first and second end surfaces. The shaft includes an inner surface defining a lumen. The cannula includes a scoop extending from the second end surface. The scoop includes an inner surface that is continuous with the inner surface of the shaft and an opposite outer surface. The cannula is inserted into the bone such that the outer surface of the scoop is positioned adjacent to the portion of the patient to be protected. A balloon is inserted into the cannula such that the balloon is positioned within the scoop. The balloon is inflated such that the balloon expands away from the scoop as the balloon is inflated and creates a void in the bone. Systems are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to surgical methods, and moreparticularly to a method of treating bone using a scoop cannula in akyphoplasty procedure. Systems are disclosed.

BACKGROUND

Height loss is commonly associated with spinal fractures, such as, forexample, vertebral compression fractures. Spinal fractures affect alarge segment of osteoporotic patients. It is estimated thatapproximately 700,000 spinal fractures occur annually from osteoporosis,for example. Procedures have been developed to treat spinal fractures.One such procedure is kyphoplasty. Kyphoplasty is a minimally invasiveprocedure that is used to treat spinal fractures, such as, for example,vertebral compression fractures by inserting one or more balloons, suchas, for example, compliant balloons inside a fractured vertebral body.The balloon or balloons are inflated within the fractured vertebral bodysuch that the cancellous bone of the vertebral body is pushed towardscortical walls of the vertebral body to form a cavity within thevertebral body. The cavity is then at least partially filled with amaterial, such as, for example, bone cement.

The balloons may be inserted into the vertebral body using a cannula,for example. Some cannulas include a scoop at the end of the cannula.The balloon engages the scoop to direct inflation of the balloon so thatthe balloon inflates away from the scoop. However, access to thevertebral body may be too inferior or superior, which creates thepotential of breaking through an endplate and/or lateral wall of thevertebral body during the inflation process, which would preventphysicians from achieving the desired procedural outcome. Thisdisclosure describes improvements over these prior art technologies.

SUMMARY

In one embodiment, a method of treating a bone of a patient includesidentifying a portion of the patient to be protected. A cannula isprovided that includes a shaft extending between opposite first andsecond end surfaces. The shaft includes an inner surface defining alumen. The cannula includes a scoop extending from the second endsurface. The scoop includes an inner surface that is continuous with theinner surface of the shaft and an opposite outer surface. The cannula isinserted into the bone such that the outer surface of the scoop ispositioned adjacent to the portion of the patient to be protected. Aballoon is inserted into the cannula such that the balloon is positionedwithin the scoop. The balloon is inflated such that the balloon expandsaway from the scoop as the balloon is inflated and creates a void in thebone. In some embodiments, system are disclosed.

In one embodiment, a method of treating a vertebra includes providing acannula including a shaft extending between opposite first and secondend surfaces. The shaft includes an inner surface defining a lumen. Thecannula includes a scoop extending from the second end surface. Thescoop includes an inner surface that is continuous with the innersurface of the shaft an opposite outer surface. A surgical pathway iscreated to the vertebra. The surgical pathway is positioned closer to afirst endplate of the vertebra than a second endplate of the vertebra.The cannula is inserted through the surgical pathway and into thevertebra such that the outer surface of the scoop is positioned adjacentto the first endplate. A balloon is inserted into the cannula such thatthe balloon is positioned within the scoop. The balloon is inflated suchthat the balloon expands away from the scoop and the first endplate andtowards the second endplate as the balloon is inflated to create a voidin the vertebra while preventing the balloon from breaking through thefirst endplate. In some embodiments, the balloon is deflated and a bonefiller material is delivered into the void. The bone filler material isallowed to cure within the void.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of one embodiment of a component of asurgical system, in accordance with the present principles of thepresent disclosure;

FIG. 2 is an end view of the component shown in FIG. 1;

FIG. 3 is a side, cross sectional view of a component of the surgicalsystem, in accordance with the present principles of the presentdisclosure;

FIG. 4 is a side, cross sectional view of the component shown in FIG. 3;

FIG. 5 is a plan view of the components shown in FIGS. 1 and 3;

FIG. 6 is a plan view of the components shown in FIGS. 1 and 3; and

FIG. 7 is a plan view of the components shown in FIGS. 1 and 3.

Like reference numerals indicate similar parts throughout the figures.

DETAILED DESCRIPTION

The exemplary embodiments of a surgical method and related systems arediscussed in terms of methods and systems for performing kyphoplasty. Insome embodiments, the system includes a scoop cannula sized for thespine, such as, for example, size 2 and size 3 scoop cannulas. A scoopcannula is akin to a standard cannula found in existing osteo introducersystem (OIS) tools, but has a cutout at the distal end. The cutoutprovides a platform for an inflatable bone tamp (IBT) to inflateagainst, thus allowing for unidirectional inflation of the IBT. Thescoop cannula can be utilized in a “rescue” situation to assistphysicians when the initial access with a standard OIS is less thanideal. If access with a standard OIS is too inferior or too superior,the IBT would have the potential of breaking through the endplate duringthe inflation process and the physicians would not be able to achievethe desired procedural outcome. The scoop cannula would be inserted downthe same access channel with the platform oriented away from the closerendplate. As a result of the scoop cannula orientation, the inflation ofthe balloon would therefore be directed towards the further endplate,protecting the closer endplate from potential rupture. The scoop cannulacould also be used in situations where the initial access was toolateral to help protect the lateral wall from rupturing during IBTinflation.

In some embodiments, one or all of the components of the surgical systemmay be disposable, peel-pack, pre-packed sterile devices. In someembodiments, the components of the surgical system are configured forone time use and are disposed after they are used one time. However, itis contemplated that one or all of the components of the surgical systemmay be reusable. The surgical system may be configured as a kit withmultiple sized and configured components, including, for example,various scoop cannulas, balloons, etc. In some embodiments, one or moreof the components of the surgical system are configured to besterilized.

In some embodiments, the disclosed surgical methods and systems may bealternatively employed in a surgical treatment with a patient in a proneor supine position, and/or employ various surgical approaches, includinganterior, posterior, posterior mid-line, direct lateral,postero-lateral, antero-lateral approaches, etc. in any body region. Themethods and systems of the present disclosure may also be used onanimals, bone models and other non-living substrates, such as, forexample, in training, testing and demonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the disclosure taken in connectionwith the accompanying drawing figures, which form a part of thisdisclosure. It is to be understood that this disclosure is not limitedto the specific devices, methods, conditions or parameters describedand/or shown herein, and that the terminology used herein is for thepurpose of describing particular embodiments by way of example only andis not intended to be limiting of the claimed disclosure. Also, as usedin the specification and including the appended claims, the singularforms “a,” “an,” and “the” include the plural, and reference to aparticular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

Further, as used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. Also, as used in the specificationand including the appended claims, the term “tissue” includes softtissue, ligaments, tendons, cartilage and/or bone unless specificallyreferred to otherwise.

The following discussion includes a description of a surgical system andrelated methods of employing the system in accordance with theprinciples of the present disclosure. Alternate embodiments are alsodisclosed. Reference will now be made in detail to the exemplaryembodiments of the present disclosure, which are illustrated in theaccompanying figures. Turning now to FIGS. 1-7, there are illustratedcomponents of a surgical system 20 in accordance with the principles ofthe present disclosure.

The components of surgical system 20 can be fabricated from biologicallyacceptable materials suitable for medical applications, includingmetals, synthetic polymers, ceramics and bone material and/or theircomposites, depending on the particular application and/or preference ofa medical practitioner. For example, the components of surgical system20, individually or collectively, can be fabricated from materials suchas stainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,stainless steel alloys, superelastic metallic alloys (e.g., Nitinol,super elasto-plastic metals, such as GUM METAL® manufactured by ToyotaMaterial Incorporated of Japan), ceramics and composites thereof such ascalcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc.),thermoplastics such as polyaryletherketone (PAEK) includingpolyetheretherketone (PEEK), polyetherketoneketone (PEKK) andpolyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyimide, polyimide, polyetherimide, polyethylene, epoxy, bone materialincluding autograft, allograft, xenograft or transgenic cortical and/orcorticocancellous bone, and tissue growth or differentiation factors,partially resorbable materials, such as, for example, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, composites of PEEK with resorbable polymers, totallyresorbable materials, such as, for example, calcium based ceramics suchas calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite(HA)-TCP, calcium sulfate, or other resorbable polymers such aspolyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe andtheir combinations. Various components of surgical system 20 may havematerial composites, including the above materials, to achieve variousdesired characteristics such as strength, rigidity, elasticity,compliance, biomechanical performance, durability and radiolucency orimaging preference. The components of surgical system 20, individuallyor collectively, may also be fabricated from a heterogeneous materialsuch as a combination of two or more of the above-described materials.The components of surgical system 20 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Surgical system 20 includes a scoop cannula, such as, for example,kyphoplasty cannula 22. Cannula 22 includes a shaft 24 that extendsalong a longitudinal axis L between a first end surface 26 and anopposite second end surface 28. Shaft 24 comprises an inner surface 30defining a lumen 32. Lumen 32 is coaxial with axis L and extends theentire length of shaft 24. Lumen 32 has a circular cross-sectionalconfiguration and a uniform diameter along the entire length of lumen32. In some embodiments, lumen 32 may have various cross sectionconfigurations, such as, for example, oval, oblong, triangular,rectangular, square, polygonal, irregular, uniform, non-uniform,variable, tubular and/or tapered. In some embodiments, lumen 32 may bedisposed at alternate orientations, relative to axis L, such as, forexample, transverse and/or other angular orientations such as acute orobtuse, co-axial and/or may be offset or staggered. Shaft 24 comprises afirst opening 34 that extends through end surface 26 and a secondopening 36 that extends through end surface 28. Openings 34, 36 are eachin communication with lumen 32.

Cannula 22 includes a semicircular plateau, such as, for example, ascoop 38 extending from end surface 28 along axis L such that scoop 38faces away from end surface 26. Scoop 38 includes an outer surface 38 athat is continuous with an outer surface 24 a of shaft 24. That is,there are no gaps or recesses between outer surface 24 a and outersurface 38 a such that outer surface 24 a smoothly transitions intoouter surface 38 a. In some embodiments, outer surface 38 a extendsparallel to outer surface 24 a and/or axis L along an entire length ofscoop 38. In some embodiments, outer surface 38 a may be disposed atalternate orientations, relative to outer surface 24 a and/or axis L,such as, for example, transverse, perpendicular and/or other angularorientations such as acute or obtuse, co-axial and/or may be offset orstaggered.

Scoop 38 includes a center portion 40 that is positioned between sideportions 42, 44 of scoop 38. Center portion 40 is configured to supporta bottom surface of a balloon as the balloon is inflated such that theballoon expands away from scoop 38 and side portions 42, 44 are eachconfigured to support a side surface of a balloon as the balloon isinflated to prevent the balloon from rolling over scoop 38 as theballoon is inflated, as discussed herein. In some embodiments, sideportions 42, 44 are each tapered from end surface 28 to a distal endsurface 52 of scoop 38. That is, side portions 42, 44 each have a heightadjacent to end surface 28 that is greater than a height of sideportions 42, 44 adjacent to distal end surface 52. In some embodiments,side portions 42, 44 are each continuously tapered from end surface 28to a distal end surface 52 of scoop 38.

Side portion 42 includes a top surface 46 and side portion 44 includes atop surface 48. Scoop 38 includes an arcuate inner surface 50 that iscontinuous with inner surface 30 of shaft 24. That is, there are no gapsor recesses between inner surface 30 and arcuate inner surface 50 suchthat inner surface 30 smoothly transitions into arcuate inner surface50. Arcuate inner surface 50 is configured to support a bottom surfaceof a balloon as the balloon is inflated to provide a backstop for theballoon to inflate against, as discussed herein. In some embodiments,arcuate inner surface 50 is concavely curved from top surface 46 to topsurface 48. In some embodiments, arcuate inner surface 50 iscontinuously curved from top surface 46 to top surface 48. That is,arcuate inner surface 50 is even or smooth and free of any gaps orprotrusions from top surface 46 to top surface 48 along the entirelength of arcuate inner surface 50. In some embodiments, arcuate innersurface 50 has a continuous radius of curvature from top surface 46 totop surface 48. In some embodiments, arcuate inner surface 50 has aradius of curvature from top surface 46 to top surface 48 that is equalto the radius of curvature of inner surface 30 of shaft 24. In someembodiments, arcuate inner surface 50 has a radius of curvature from topsurface 46 to top surface 48 that is greater than the radius ofcurvature of inner surface 30 of shaft 24. In some embodiments, arcuateinner surface 50 has a radius of curvature from top surface 46 to topsurface 48 that is less than the radius of curvature of inner surface 30of shaft 24.

In some embodiments, outer surface 38 a of scoop 38 is convexly curvedfrom top surface 46 to top surface 48. In some embodiments, outersurface 38 a is continuously curved from top surface 46 to top surface48. That is, outer surface 38 a is even or smooth and free of any gapsor protrusions from top surface 46 to top surface 48 along the entirelength of outer surface 38 a. In some embodiments, outer surface 38 ahas a continuous radius of curvature from top surface 46 to top surface48. In some embodiments, outer surface 38 a has a radius of curvaturefrom top surface 46 to top surface 48 that is equal to the radius ofcurvature of outer surface 24 a of shaft 24. In some embodiments, outersurface 38 a has a radius of curvature from top surface 46 to topsurface 48 that is greater than the radius of curvature of outer surface24 a of shaft 24. In some embodiments, outer surface 38 a has a radiusof curvature from top surface 46 to top surface 48 that is less than theradius of curvature of outer surface 24 a of shaft 24.

In some embodiments, shaft 24 and/or scoop 38 are made from a shapememory material. In some embodiments, shaft 24 and/or scoop 38 are madefrom a superelastic material. In some embodiments, shaft 24 and/or scoop38 are made from super-elastic Nitinol. In some embodiments, shaft 24and/or scoop 38 are made from a material that will deform elasticallyand then return to its original shape to minimize the effects ofdeformation. For example, shaft 24 and/or scoop 38 are made fromsuper-elastic Nitinol such that side portions 42, 44 will deflectrelative to center portion 40 when the balloon is inflated and thenreturn to their original shape after the balloon is deflated. In someembodiments, shaft 24 and/or scoop 38 are made from a rigid materialthat cannot bend and/or deform without breaking. In some embodiments,shaft 24 is made from a rigid material that cannot bend and/or deformwithout breaking and scoop 38 is made from a shape memory material or asuperelastic material. In some embodiments, scoop 38 is made from arigid material that cannot bend and/or deform without breaking and shaft24 is made from a shape memory material or a superelastic material.

System 20 includes a balloon catheter, such as, for example, aninflatable bone tamp 58. In one embodiment, shown in FIGS. 3 and 4,inflatable bone tamp 58 includes an outer tube, such as, for example, atube 60 and a balloon 62 that is coupled to an end of tube 60. Aninflation material, such as, for example, air, saline, or a contrastsolution may be delivered through tube 60 and into balloon 62 to moveballoon 62 from an uninflated orientation shown in FIG. 3 to an inflatedorientation shown in FIG. 4. In some embodiments, balloon 62 isconfigured to expand radially about a longitudinal axis L1 defined bytube 60, as shown in FIGS. 3 and 4. In some embodiments, balloon 62 mayconfigured to expand in only one direction. For example, balloon 62 maybe made such that a top portion of balloon 62 is thicker or comprises adifferent material than a bottom portion of balloon 62 such that thebottom portion of balloon 62 will expand more than the top portion ofballoon 62 when balloon 62 is inflated.

Inflatable bone tamp 58 is configured for insertion into cannula 22 suchthat tube 60 is positioned within lumen 32 of shaft 24 and balloon 62 ispositioned within scoop 38, as shown in FIGS. 5 and 6. In someembodiments, axis L is coaxial with axis L1 when inflatable bone tamp 58is inserted into cannula 22. When balloon 62 is positioned within scoop38, a bottom surface 62 a of balloon 62 directly engages arcuate innersurface 50, a first side surface 62 b of balloon 62 directly engagesside portion 42 and an opposite second side surface 62 c of balloon 62directly engages side portion 44. As balloon 62 moves from theuninflated orientation to the inflated orientation, arcuate innersurface 50 supports bottom surface 62 a of balloon 62 as balloon 62 isinflated to provide a backstop for balloon 62 to inflate against suchthat balloon 62 expands away from arcuate inner surface 50. Becauseballoon 62 expands away from scoop 38, a centerline C of balloon 62 isoffset from axis L when balloon 62 is inflated, as shown in FIG. 6. Insome embodiments, centerline C of balloon 62 may be coaxial with axis Lwhen balloon 62 is uninflated, as shown in FIG. 5. Side portion 42 ofscoop 38 supports side surface 62 b of balloon 62 and side portion 44 ofscoop 38 supports side surface 62 c of balloon as balloon 62 moves fromthe uninflated orientation to the inflated orientation to preventballoon 62 from rolling over scoop 38 as balloon 62 is inflated.

In operation and use, to treat a bone disorder, such as, for example, aspinal fracture, a medical practitioner obtains access to a targetlocation including at least one bony structure, such as, for example, afractured vertebra, in any appropriate manner, such as through incisionand retraction of tissue. It is envisioned that the surgical system 20may be used in any existing surgical method or technique including opensurgery, mini-open surgery, minimally invasive surgery includingpercutaneous surgical implantation, whereby a vertebra of a patient isaccessed through a micro-incision, or sleeve that provides a protectedpassageway to the area. Once access to the surgical site(s) areobtained, the particular surgical procedure is performed for treatingthe bone disorder.

A portion 64 of the patient is identified to be protected duringinflation of balloon 62. In some embodiments, portion 64 is identifiedusing computed tomography scan (CT), magnetic resonance image (MRI), CTcapable fluoroscopy or similar two dimensional imaging study. In someembodiments, portion 64 is identified using radiography, via either aquantitative or semi-quantitative assessment. In some embodiments, aradiopaque contrast material is injected into the bone for visualizationunder radiographic imaging (fluoroscopy). In some embodiments, portion64 is identified using an x-ray scan. In some embodiments, using eitherradiology or an x-ray scan, the image of a bone, such as, for example, avertebra may be compared against other images to determine if the boneincludes a fracture and/or other defect based on the shape of the boneand the shape of the bone(s) in the other images. In some embodiments,using either radiology or an x-ray scan, the image of a bone, such as,for example, a vertebra may be compared against mathematical models ofnormal bone to determine if the bone includes a fracture and/or otherdefect, using neighboring vertebrae as predictors of the unfracturedshape of verterbrae. In some embodiments, portion 64 is identified usingvertebral morphology techniques. In some embodiments, portion 64 isidentified using a digital densitometry device that generates broadlybased values of bone character, such as bone mineral content or bonemineral density. That is, portion 64 may be identified as a portion ofbone having bone mineral content and/or bone mineral density below aselected threshold.

In some embodiments, portion 64 is a nerve in or around a vertebra. Insome embodiments, portion 64 is a bone fracture in or around a vertebra.In some embodiments, portion 64 is an endplate of a vertebra wherein theendplate includes a defect and/or is otherwise damaged. In someembodiments, portion 64 is a lateral wall of a vertebra. A surgicalpathway is created to a bone, such as, for example, a vertebra. In someembodiments, the surgical pathway is positioned closer to a firstendplate of the vertebra than a second endplate of the vertebra. In someembodiments, the surgical pathway is positioned closer to a firstlateral wall of the vertebra than a second lateral wall of the vertebra.Inflatable bone tamp 58 is inserted into cannula 22 such that tube 60 ispositioned within lumen 32 of shaft 24 and balloon 62 is positionedwithin scoop 38. Scoop 38 and balloon 62 are inserted through thesurgical pathway and into a vertebral body of the vertebra such thatscoop 38 is positioned adjacent to portion 64, as shown in FIG. 7. Insome embodiments, inflatable bone tamp 58 is inserted into cannula 22before cannula 22 is inserted into the vertebral body. In someembodiments, inflatable bone tamp 58 is inserted into cannula 22 aftercannula 22 is inserted into the vertebral body.

In some embodiments, inflatable bone tamp 58 is inserted into cannula 22such that balloon 62 is positioned entirely within scoop 38 such thatballoon 62 will expand away from scoop 38 as balloon 62 is inflated. Insome embodiments, a distal end of balloon 62 is recessed inwardly from adistal end of scoop 38. In some embodiments, the distal end of balloon62 is flush with the distal end of scoop 38. In some embodiments,inflatable bone tamp 58 is inserted into cannula 22 such that the distalend of balloon 62 is distal to the distal end of scoop 38. In someembodiments, the distal end of balloon 62 laps over the distal end ofscoop 38. In such embodiments, balloon 62 is a unidirectional balloonsuch that the portion of balloon 62 that is distal to the distal end ofscoop 38 will expand away from portion 64. It is envisioned that balloon62 may have walls with varying thickness, for example, to provideballoon 62 with unidirectional expansion capabilities.

In one embodiment wherein portion 64 is a nerve, cannula 22 may bepositioned relative to the nerve such that outer surface 38 a of scoop38 faces the nerve and inner surface 50 of scoop 38 faces away from thenerve. In one embodiment wherein portion 64 is a nerve, cannula 22 maybe positioned relative to the nerve such that outer surface 38 a ofscoop 38 directly engages the nerve. Balloon 62 is then moved from theuninflated orientation to the inflated orientation. As balloon 62 movesfrom the uninflated orientation to the inflated orientation, arcuateinner surface 50 of scoop 38 supports bottom surface 62 a of balloon 62as balloon 62 is inflated to provide a backstop for balloon 62 toinflate against such that balloon 62 expands away from the nerve. Thisallows a medical practitioner to direct balloon 62 away from the nerve.For example, scoop 38 may be used to direct balloon 62 away from portion64 and toward a wall of an endplate 66 of the vertebra, as shown in FIG.7. As discussed herein, scoop 38 helps to distribute the load created byballoon 62 against the vertebra to increase the lifting force of balloon62. As balloon 62 moves from the uninflated orientation to the inflatedorientation, balloon 62 creates a void space within the vertebra.

In one embodiment wherein portion 64 is a bone fracture, cannula 22 maybe positioned relative to the bone fracture such that outer surface 38 aof scoop 38 faces the bone fracture and inner surface 50 of scoop 38faces away from the bone fracture. In one embodiment wherein portion 64is a bone fracture, cannula 22 may be positioned relative to the bonefracture such that outer surface 38 a of scoop 38 directly engages thebone fracture. In some embodiments, scoop 38 may be positioned such thatscoop 38 extends across the bone fracture. In some embodiments, scoop 38may be positioned such that axis L extends parallel to the bonefracture. In some embodiments, scoop 38 may be positioned such that axisL extends transverse to the bone fracture. Balloon 62 is then moved fromthe uninflated orientation to the inflated orientation. As balloon 62moves from the uninflated orientation to the inflated orientation,arcuate inner surface 50 of scoop 38 supports bottom surface 62 a ofballoon 62 as balloon 62 is inflated to provide a backstop for balloon62 to inflate against such that balloon 62 expands away from the bonefracture. This allows a medical practitioner to direct balloon 62 awayfrom the bone fracture. For example, scoop 38 may be used to directballoon 62 away from the bone fracture and toward endplate 66 of thevertebra, as shown in FIG. 7. As discussed herein, scoop 38 helps todistribute the load created by balloon 62 against the vertebra toincrease the lifting force of balloon 62. As balloon 62 moves from theuninflated orientation to the inflated orientation, balloon 62 creates avoid space within the vertebra.

In one embodiment wherein portion 64 is a first endplate of thevertebra, such as, for example, a damaged and/or weakened first endplateof the vertebra, cannula 22 may be positioned relative to the firstendplate such that outer surface 38 a of scoop 38 faces the firstendplate and inner surface 50 of scoop 38 faces away from the firstendplate. In one embodiment wherein portion 64 is a damaged and/orweakened first endplate of the vertebra, cannula 22 may be positionedrelative to the first endplate such that outer surface 38 a of scoop 38directly engages the first endplate. For example, cannula 22 may bepositioned such that outer surface 38 a of scoop 38 directly engages abony layer of the first endplate. In some embodiments, scoop 38 directlyengages a ring apophysis of the vertebra when outer surface 38 a ofscoop 38 directly engages a bony layer of the first endplate. In someembodiments, cannula 22 may be positioned between a bony layer of thefirst endplate and a layer of hyaline cartilage of the vertebra. In someembodiments, scoop 38 may be positioned such that scoop 38 extendsacross the first endplate. Balloon 62 is then moved from the uninflatedorientation to the inflated orientation. As balloon 62 moves from theuninflated orientation to the inflated orientation, arcuate innersurface 50 of scoop 38 supports bottom surface 62 a of balloon 62 asballoon 62 is inflated to provide a backstop for balloon 62 to inflateagainst such that balloon 62 expands away from the first endplate. Thisallows a medical practitioner to direct balloon 62 away from the firstendplate. For example, scoop 38 may be used to direct balloon 62 awayfrom the first endplate and toward endplate 66 of the vertebra, as shownin FIG. 7. As discussed herein, scoop 38 helps to distribute the loadcreated by balloon 62 against the vertebra to increase the lifting forceof balloon 62. As balloon 62 moves from the uninflated orientation tothe inflated orientation, balloon 62 creates a void space within thevertebra between endplate 64 and endplate 66.

In one embodiment wherein portion 64 is a first lateral wall of thevertebra, such as, for example, a damaged and/or weakened first lateralwall of the vertebra that is positioned between first and secondendplates of the vertebra, cannula 22 may be positioned relative to thefirst lateral wall such that outer surface 38 a of scoop 38 faces thefirst lateral wall and inner surface 50 of scoop 38 faces away from thefirst lateral wall. In one embodiment wherein portion 64 is a damagedand/or weakened first lateral wall of the vertebra that is positionedbetween first and second endplates of the vertebra, cannula 22 may bepositioned relative to the first lateral wall such that outer surface 38a of scoop 38 directly engages the first lateral wall. In someembodiments, scoop 38 may be positioned such that scoop 38 extendsacross the first lateral wall. Balloon 62 is then moved from theuninflated orientation to the inflated orientation. As balloon 62 movesfrom the uninflated orientation to the inflated orientation, arcuateinner surface 50 of scoop 38 supports bottom surface 62 a of balloon 62as balloon 62 is inflated to provide a backstop for balloon 62 toinflate against such that balloon 62 expands away from the first lateralwall. This allows a medical practitioner to direct balloon 62 away fromthe first lateral wall. For example, scoop 38 may be used to directballoon 62 away from the first lateral wall and toward a second lateralwall 66 of the vertebra, as shown in FIG. 7. As discussed herein, scoop38 helps to distribute the load created by balloon 62 against thevertebra to increase the lifting force of balloon 62. As balloon 62moves from the uninflated orientation to the inflated orientation,balloon 62 creates a void space within the vertebra between lateral wall64 and lateral wall 66.

In one embodiment, balloon 62 is deflated and inflatable bone tamp 58 isremoved from cannula 22 after balloon 62 creates the void space withinthe vertebra. A bone filler material is inserted through cannula 22 andinto the void space within the vertebra. In one embodiment, balloon 62is deflated and cannula 22 and inflatable bone tamp 58 are removed fromthe vertebra after balloon 62 creates the void space within thevertebra. A second cannula (not shown) is inserted into the vertebrasuch that an end of the second cannula is positioned within the voidspace. A bone filler material is delivered through the second cannulaand into the void space to fill all or a portion of the void space. Insome embodiments, the bone filler material is a curable bone fillermaterial, such as, for example, a polymethylmethacrylate based bonecement. The bone cement then cures within the vertebra to treat thevertebra by reducing pain, stabilizing the vertebra and/or restoring thevertebra back to its normal height.

In some embodiments, a kit containing one or more components of surgicalsystem 20 is provided. The kit may comprise components from any of theembodiments discussed herein. In some embodiments, the kit comprises oneor more of the inflation materials discussed herein. In someembodiments, the kit comprises one or more bone filler materials, suchas, for example, bone cements made from polymethylmethacrylate. In someembodiments, the kit comprises a plurality of cannulas, such as, forexample, cannulas 22 having different lengths configured for use withdifferent size patients. In some embodiments, the kit comprises aplurality of cannulas, such as, for example, cannulas 22 having scoops38 with different widths and/or lengths configured for use withdifferent size balloons.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A method of treating a bone of a patient, themethod comprising: identifying a portion of the patient to be protected;providing a cannula comprising a shaft extending between opposite firstand second end surfaces, the shaft comprising an inner surface defininga lumen, the cannula comprising a scoop extending from the second endsurface, the scoop comprising an inner surface that is continuous withthe inner surface of the shaft an opposite outer surface; inserting thecannula into the bone such that the outer surface of the scoop ispositioned adjacent to the portion of the patient to be protected;inserting a balloon into the cannula such that the balloon is at leastpartially positioned within the scoop; and inflating the balloon suchthat the balloon expands away from the scoop as the balloon is inflatedand creates a void in the bone.
 2. A method as recited in claim 1,wherein the outer surface of the scoop faces the portion of the patientto be protected.
 3. A method as recited in claim 1, wherein the outersurface of the scoop directly engages the portion of the patient to beprotected.
 4. A method as recited in claim 1, wherein the portion of thepatient to be protected is a nerve.
 5. A method as recited in claim 1,wherein the portion of the patient to be protected is a fracture in thebone.
 6. A method as recited in claim 5, wherein the outer surface ofthe scoop extends across the bone fracture.
 7. A method as recited inclaim 1, wherein the bone is a vertebra and the portion of the patientto be protected is a first endplate of the vertebra.
 8. A method asrecited in claim 7, wherein the balloon expands away from the firstendplate to prevent the balloon from breaking through the firstendplate.
 9. A method as recited in claim 7, wherein the balloon expandsaway from the first endplate such that the balloon expands towards asecond endplate of the vertebra.
 10. A method as recited in claim 7,wherein the outer surface of the scoop faces the first endplate and theinner surface of the scoop faces a second endplate of the vertebra. 11.A method as recited in claim 7, wherein the scoop is positioned closerto the first endplate than a second endplate of the vertebra.
 12. Amethod as recited in claim 7, wherein the cannula is inserted betweenthe first endplate and a second endplate of the vertebra.
 13. A methodas recited in claim 1, wherein the bone is a vertebra and the methodfurther comprises creating a surgical pathway to the bone beforeinserting the cannula into the bone, the surgical pathway beingpositioned closer to a first endplate of the vertebra than a secondendplate of the vertebra.
 14. A method as recited in claim 1, whereinthe bone is a vertebra and the method further comprises creating asurgical pathway to the bone before inserting the cannula into the bone,the surgical pathway being positioned closer to a first lateral wall ofthe vertebra than a second lateral wall of the vertebra.
 15. A method asrecited in claim 1, further comprising: deflating the balloon; removingthe balloon from the cannula; delivering a bone filler material throughthe cannula and into the void; and allowing the bone filler material tocure within the void.
 16. A method as recited in claim 15, wherein thebone filler material is a polymethylmethacrylate based bone cement. 17.A method as recited in claim 1, further comprising: deflating theballoon; removing the cannula from the bone; inserting a second cannulainto the bone such that an end of the second cannula is positionedwithin the void; and delivering a bone filler material through thesecond cannula and into the void; and allowing the bone filler materialto cure within the void.
 18. A method as recited in claim 17, whereinthe bone filler material is a polymethylmethacrylate based bone cement.19. A method of treating a vertebra, the method comprising: providing acannula comprising a shaft extending between opposite first and secondend surfaces, the shaft comprising an inner surface defining a lumen,the cannula comprising a scoop extending from the second end surface,the scoop comprising an inner surface that is continuous with the innersurface of the shaft an opposite outer surface; creating a surgicalpathway to the vertebra, the surgical pathway being positioned closer toa first endplate of the vertebra than a second endplate of the vertebra;inserting the cannula through the surgical pathway and into the vertebrasuch that the outer surface of the scoop is positioned adjacent to thefirst endplate; inserting a balloon into the cannula such that theballoon is positioned within the scoop; and inflating the balloon suchthat the balloon expands away from the scoop and the first endplate andtowards the second endplate as the balloon is inflated to create a voidin the vertebra while preventing the balloon from breaking through thefirst endplate and.
 20. A method of treating a vertebra, the methodcomprising: providing a cannula comprising a shaft extending betweenopposite first and second end surfaces, the shaft comprising an innersurface defining a lumen, the cannula comprising a scoop extending fromthe second end surface, the scoop comprising an inner surface that iscontinuous with the inner surface of the shaft and an opposite outersurface; creating a surgical pathway to the vertebra, the surgicalpathway being positioned closer to a first endplate of the vertebra thana second endplate of the vertebra; inserting the cannula through thesurgical pathway and into the vertebra such that the outer surface ofthe scoop is positioned adjacent to the first endplate; inserting aballoon into the cannula such that the balloon is positioned within thescoop; inflating the balloon such that the balloon expands away from thescoop and the first endplate and towards the second endplate as theballoon is inflated to create a void in the vertebra while preventingthe balloon from breaking through the first endplate; deflating theballoon; delivering a bone filler material into the void; and allowingthe bone filler material to cure within the void.